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A Prospective, Single-arm, Multi-centre, Observational, Real World Registry (Morpheus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02901353
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Meril Life Sciences Pvt. Ltd.

Brief Summary:
A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.

Condition or disease Intervention/treatment
Angina Pectoris Device: Sirolimus Eluting Coronary Stent System

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: A Prospective, Single-arm, Multi-centre, Observational, Real World Registry to Evaluate Safety and Performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for Very Long Coronary Lesions.
Actual Study Start Date : February 2, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
Drug Information available for: Sirolimus


Intervention Details:
  • Device: Sirolimus Eluting Coronary Stent System
    Patient with Angina Pectoris will be enrolled for the intervention


Primary Outcome Measures :
  1. Freedom of target lesion failure [ Time Frame: TLF at 6 month and up to 24 month ]

Secondary Outcome Measures :
  1. MACE [ Time Frame: 1, 6, 12 and 24 month ]
  2. Target vessel failure [ Time Frame: 1, 6, 12 and 24 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The utilization of the BioMime™ Morph Sirolimus Eluting Coronary Stent System implantation in very long (length ≤ 56 mm) coronary lesions in native coronary arteries with reference vessel diameter of 2.25 mm to 3.50 mm.
Criteria

Inclusion Criteria:

  1. The patient must be at least 18 years of age.
  2. Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of ≤56mm.
  3. The patient or guardian agrees to the protocol requirements and the schedule of follow-up and provides informed written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site -

Exclusion Criteria:

  1. Patients contraindicated to any of the following medications: aspirin, heparin, clopidogrel, cobalt-chromium, contrast agents and sirolimus.
  2. An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrolment.
  3. Patients who are actively participating in another drug or device investigational study.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901353


Contacts
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Contact: Ashok Thakkar, Ph.D +91 9879443584 ashok.thakkar@merillife.com
Contact: Kartik Vyas, M.Sc. +91 9619129010 kartik.vyas@merillife.in

Locations
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Hungary
University of Semmelweis Recruiting
Budapest, Europe, Hungary, 1085
Contact: Prof. Dr. Bela Merkely, MD, Ph.D, D.Sc       Merkely.Bela@kardio.sote.hu   
University of Debrecen Recruiting
Debrecen, Europe, Hungary, 4032
Contact: Dr. Szűk Tibor, Ph.D, MD       tszuk01@gmail.com   
Jordan
Jordan Hospital Recruiting
Amman, Jordan
Contact: Dr. Imad A Haddad, MD       alhaddad63@gmail.com   
Malaysia
University Malaya Medical Centre (UMMC) Recruiting
Kuala Lumpur, Selangor, Malaysia, 59100
Contact: Dr. Ramesh Singh, MBBS, MRCP       ramesh@ummc.edu.my   
Netherlands
St. Antonius Hospital Recruiting
Nieuwegein, Germany, Netherlands, 3435CM
Contact: Dr. P. Agostoni         
Sponsors and Collaborators
Meril Life Sciences Pvt. Ltd.
Investigators
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Principal Investigator: Prof. Dr. Bela Merkely, MD, Ph.D, D.Sc University of Semmelweis
Principal Investigator: Dr. Szűk Tibor, Ph.D, MD University of Debrecen
Principal Investigator: Dr. P. Agostoni, Ph.D, MD St. Antonius Nieuwegein
Principal Investigator: Dr. Imad A Haddad, MD Jordan Hospital
Principal Investigator: Dr. Ramesh Singh, MBBS, MRCP University Malaya Medical Centre (UMMC)

Additional Information:

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Responsible Party: Meril Life Sciences Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02901353     History of Changes
Other Study ID Numbers: BIO/MOR-I
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs